NCT05423756

INSPIRE Trial for Skin and Soft Tissue Infections

The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118,562 (actual)
• Sponsor: Harvard Pilgrim Health Care · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen. Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.

Conditions

• Skin and Soft Tissue (SST) Infection

Interventions

Type	Name	Description
OTHER	Arm 1: Routine Care	Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
OTHER	Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection	Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-05-09
• Completion: 2024-05-09
• First posted: 2022-06-21
• Last updated: 2025-08-26
• Results posted: 2025-08-26

Locations

102 sites across 1 country: United States